Evaluation of the Timing of the Nebulization Related to the Physiotherapy Session

Not Applicable

Completed

• Conditions: Cystic Fibrosis
• Interventions: Drug: Amikacin nebulization; Procedure: Airway clearance technique

• Registration Number: NCT02201082
• Lead Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Brief Summary

The purpose of this study is to determine the optimal time for the nebulization depending on the respiratory physiotherapy session in cystic fibrosis patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09
• Primary Completion: 2013-07
• Study First Submitted: 2014-02-20
• Study First Submitted QC: 2014-07-24
• Study First Posted: 2014-07-25
• Study Completion: 2015-07
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-24
• Last Update Posted: 2015-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• Stable cystic fibrosis patients older than 16 y.o.
• Pseudomonas aeruginosa colonization
• Hypersecretion

Exclusion Criteria

• Kidney failure
• No pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nebulization	Amikacin nebulization	nebulization
Nebulization and airway clearance technique	Airway clearance technique	nebulization combined to airway clearance
Nebulization and airway clearance technique	Amikacin nebulization	nebulization combined to airway clearance

Primary Outcome Measures

Name	Time	Method
Urinary excretion of amikacin	24h after the nebulization	Pharmacokinetic study of the urinary excretion of amikacin after nebulization

Secondary Outcome Measures

Name	Time	Method
Amikacin concentration into the sputum	At the end of the nebulization, an expected average of 20 minutes

Trial Locations

Locations (1)

Cliniques universitaires Saint-Luc; 🇧🇪 Brussels, Belgium